Aktis Oncology Reports Third-Quarter Financial Results and Highlights Clinical Trial Progress

(NASDAQ:AKTS) Aktis Oncology, Inc. reported financial results for the third quarter ended September 30, 2026, and provided a business update on its clinical-stage radiopharmaceutical programs. The company is advancing three clinical trials in the U.S. across two novel targets, Nectin-4 and B7-H3, implicated in various solid tumor types. Aktis initiated the BActinium-2 trial of AKY-2519 and opened the first backfill cohorts in the NECTINIUM-2 and BActinium-1 trials to further characterize safety and preliminary antitumor activity at selected doses, with dose escalation ongoing in both studies. AKY-1189 is being evaluated in the Phase 1b NECTINIUM-2 trial for patients with locally advanced or metastatic urothelial cancer and other Nectin-4 expressing solid tumors, with backfill at the 6 MBq dose level for up to 30 patients. AKY-2519 is being evaluated in the Phase 1b BActinium-2 trial for non-small cell lung cancer and other B7-H3 expressing tumors, and in the Phase 1b BActinium-1 trial for metastatic castration-resistant prostate cancer, with backfill at the 9 MBq dose level for up to 30 patients per cohort. Aktis operationalized its in-house GMP facility at 17 Drydock in Boston and expects to begin supplying drug product for clinical trials in the first half of 2027. The company intends to amend the INDs for AKY-2519 and AKY-1189 to include the in-house facility as a manufacturer of clinical supply. Preliminary data from the NECTINIUM-2 trial is expected in the first quarter of 2027, and from the BActinium-1 trial in 2027. Two early pipeline programs are tracking toward development candidate nomination and IND-enabling activities in the first quarter of 2027. Cash, cash equivalents, and marketable securities were $492.9 million as of September 30, 2026, compared with $226.8 million as of December 31, 2025. Collaboration revenue was $3.9 million for the quarter ended September 30, 2026, compared with $1.6 million for the prior-year period, with the increase attributable to the Eli Lilly and Company collaboration. Research and development expenses were $32.1 million for the quarter, up from $16.5 million, primarily due to advancement of clinical trials and increased headcount. General and administrative expenses were $6.5 million, up from $3.3 million, mainly due to increased headcount and public company activities. Net loss was $29.9 million for the quarter, compared with $15.5 million for the prior-year period, with the increase driven by higher operating expenses. For the nine months ended September 30, 2026, collaboration revenue was $10.5 million, research and development expenses were $77.4 million, general and administrative expenses were $19.4 million, and net loss was $72.4 million. As of September 30, 2026, total assets were $532.5 million, total liabilities were $73.6 million, and total stockholders' equity and redeemable convertible preferred stock was $458.9 million. The company’s cash position is expected to fund its operating plan into 2029. Aktis has a discovery collaboration with Eli Lilly and Company to develop novel radioconjugates outside its proprietary pipeline.

Aktis Oncology Reports First-in-Human Clinical Imaging and Dosimetry Data for AKY-2519 Demonstrating Robust Tumor Uptake and Limited Normal Tissue Exposures in Patients with B7-H3 Expressing Tumors

Aktis Oncology, Inc. (NASDAQ:AKTS) announced first-in-human clinical imaging and dosimetry data for AKY-2519, a miniprotein radioconjugate targeting B7-H3 expressing tumors, to be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The data, from assessments in metastatic castration-resistant prostate cancer (mCRPC) and various solid tumors, demonstrated robust tumor uptake and limited normal tissue exposure. Safety results showed AKY-2519 was generally well tolerated with no adverse events or infusion-related reactions. Predicted absorbed doses in key normal tissues were favorable compared to clinical benchmarks, with notably lower salivary gland exposure. Tumor absorbed doses were within expected therapeutic ranges, and high standardized uptake values (SUV max) were observed in prostate, lung, and rectal cancers. Aktis is enrolling patients in a Phase 1b trial in mCRPC and plans to initiate a second Phase 1b trial in other B7-H3 expressing tumors in the second half of 2026, with preliminary data anticipated in 2027. The company will host a conference call on May 27, 2026, to discuss these results.

Aktis Oncology Reports Financial Results and Business Highlights for First Quarter 2026

Aktis Oncology, Inc. (NASDAQ:AKTS) announced the initiation of a Phase 1b clinical trial of AKY-2519 in metastatic castration-resistant prostate cancer (mCRPC), with preliminary data expected in 2027. The company also reported financial results for the first quarter ended March 31, 2026, including cash, cash equivalents and marketable securities of $538.5 million and a net loss of $18.3 million. Aktis completed an initial public offering in January 2026, raising approximately $365.4 million in gross proceeds. The company is advancing two clinical-stage programs, AKY-1189 and AKY-2519, and expects to present clinical imaging and dosimetry data at the 2026 ASCO Annual Meeting. These developments are significant as they demonstrate progress in clinical trials and strengthen the company's financial position.

Aktis Oncology Initiates Phase 1b Clinical Trial for AKY-2519, a B7-H3 Miniprotein Radioconjugate, in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Aktis Oncology, Inc. (NASDAQ:AKTS) announced the initiation of a Phase 1b clinical trial of AKY-2519 in patients with metastatic castration-resistant prostate cancer (mCRPC). The company is also planning a second Phase 1b basket trial in lung, colorectal, and other high B7-H3 expressing solid tumors in the second half of 2026. Preliminary mCRPC data are expected in 2027, and preliminary data for AKY-1189 are anticipated in the first quarter of 2027. Aktis will hold a conference call on May 5, 2026, at 8 a.m. ET to discuss its clinical development strategy. These trials aim to address unmet needs in solid tumor treatment and expand the use of targeted radiopharmaceuticals.

Aktis Oncology Announces Presentation of First Clinical Imaging and Dosimetry Data for AKY-2519 at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting

Aktis Oncology, Inc. announced that clinical imaging and dosimetry data of AKY-2519 in patients with various B7-H3 expressing solid tumors will be presented in two poster presentations at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The meeting will be held from May 29 to June 2, 2026, in Chicago. Aktis Oncology, Inc. is a clinical-stage oncology company focused on targeted radiopharmaceuticals. This announcement highlights the company's ongoing clinical research and upcoming data presentation.